Isotechnika Reports Final Safety and Efficacy Data From Phase III Psoriasis Extension Trial
Edmonton, Canada (ots/PRNewswire)
Isotechnika Inc. (TSX:ISA) reports final safety and efficacy data subsequent to 60 weeks of continuous treatment with ISA247. All safety and efficacy endpoints were met.
Patients completing the 24 week Canadian Phase III SPIRIT trial were given the opportunity to continue ISA247 therapy at a 0.3 mg/kg twice daily oral dose for an additional 36 weeks. The goal of the extension trial was to gather long term safety data while demonstrating continued therapeutic benefit.
Patients have now received continuous treatment with ISA247 for a total of 60 weeks. Over the course of the 24-week Phase III trial, patients exhibited a 60% mean improvement in Psoriasis Area and Severity Index (PASI) scores. After an additional 36 weeks of treatment, there was a 54% mean improvement in PASI scores indicating continued therapeutic benefit. This beneficial effect was still observed twelve weeks after discontinuing ISA247 treatment; mean PASI scores remained at 35% below pre-treatment scores.
Subsequent to 60 weeks of continuous treatment, there were no clinically significant changes in kidney function, cholesterol, triglycerides, new onset diabetes, infectious complications, or other laboratory parameters. This supports the long term safety of ISA247.
"The heartening experience portending a new psoriasis medication continues as the efficacy and safety are confirmed in a longer study," stated Dr. Robert Auerbach, Clinical Professor of Dermatology, New York University School of Medicine.
"We are pleased that the final 60 week data is consistent with all previously reported data on the drug," added Dr. Randall Yatscoff, Isotechnika's President & CEO. "The purpose of the extension trial was to generate longer term safety and efficacy data. All of the endpoints of this trial have been successfully achieved. In addition, the majority of patients exhibited continued therapeutic benefit subsequent to discontinuation of drug."
Dr. Yatscoff will present the final 60 week data at BioContact at 2:30 p.m. ET/12:30 p.m. MT this afternoon. All interested parties are encouraged to view the presentation on the Company's corporate web site at www.isotechnika.com. The presentation will be loaded onto the web site in conjunction with Dr. Yatscoff's live presentation.
About Isotechnika
Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world- class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 has successfully completed a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a North American Phase IIb human clinical trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which successfully completed Phase I clinical trials.
Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found at www.isotechnika.com.
Partnerships
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche on April 9, 2002, which licensed the worldwide rights to develop and commercialize ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into an exclusive worldwide licensing agreement with Atrium Medical Corporation for the use of ISA247 and TAFA93 specifically with drug eluting devices for the non- systemic treatment of vascular, cardiovascular, target vessel and tissue disorders.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive license to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of ISA247 in patients suffering from mild to moderate psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
Forward-Looking Statements
This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc.,
+1-(780)-487-1600 (246), +1-(780)-484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1-(780)-909-4661,
+1-(780)-484-4105 (fax), sgillis-paulgaard@isotechnika.com